BioWorld Perspectives » ethicshttp://www.bioworld.com/perspectives
news, analysis, debates, commentary and camaraderie related to the development of biotechnology drugsFri, 20 Feb 2015 16:50:56 +0000en-UShourly1http://wordpress.org/?v=3.5Human germline engineering: The mom’s not in the picturehttp://www.bioworld.com/perspectives/2014/03/04/human-germline-engineering-moms-picture/
http://www.bioworld.com/perspectives/2014/03/04/human-germline-engineering-moms-picture/#commentsTue, 04 Mar 2014 14:17:28 +0000Anette Breindlhttp://www.bioworld.com/perspectives/?p=1543U.S. and British government agencies are moving toward enabling what would be the first clinical trials of what is, in effect, human germline engineering – genetic modifications that would be passed down through the generations. The modifications would not be...

]]>U.S. and British government agencies are moving toward enabling what would be the first clinical trials of what is, in effect, human germline engineering – genetic modifications that would be passed down through the generations.

The modifications would not be made to nuclear DNA. Instead, the procedure being considered is oocyte modification – creating an egg cell with the nuclear DNA of one woman and the mitochondrial DNA of another. The goal would be to allow women with mitochondrial diseases to have babies that share their nuclear DNA, but are not at risk of inheriting their mitochondrial disease.

The UK has published draft guidelines on legalizing mitochondria donation for public comment, and at the FDA, an advisory committee discussed “oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility” for two days last week.

At the FDA’s meeting, advisory committee member John Gearhart lamented the media headlines on “designer babies,” saying that it was necessary to “proactively [and] prospectively” address such concerns to keep the discussion from going off the rails.

Such going off the rails, he said, would be “the same problem that clobbered us in stem cells for years and years.”

Well, I certainly agree that it’s good to be proactive with the media. Call me any time!

But I cannot agree that oocyte modification, underneath the surface, has all that much in common with stem cell research.

Stem cells are about exploring the potential of something that is not a person to benefit somebody who is a person, a person who is alive and suffering from disease here and now.

The goal of oocyte modification is to create the very person that is to benefit from the procedure. Ethically speaking, that’s a very different proposal.

To top it, off, what I’ve seen of the discussion has ignored a major swath of ethical questions – those that relate to the mothers.

First off, let me say what I’m not concerned about.

It’s not natural

Don’t get me started on whether this is natural. I’d like to formally nominate “natural” as the most overrated concept in Western healthcare today. Natural childbirth was once among the biggest health risks women and babies faced. Romanticizing the natural a little less would do us all good. Give me human ingenuity over nature red in tooth and claw every time.

And while I do agree that both germline engineering and the health risks to any children that would be created using oocyte modification are real ethical and medical issues ‑ three-parent IVF really is different from regular IVF, and certainly from stem cell therapies, in creating genetically alterations that are passed down through generations – those issues have gotten an airing elsewhere and will continue to be discussed.

What’s notably absent in at least the lay public’s discussions, though, is the mothers.

As I was listening to the FDA’s advisory committee meeting on oocyte modification last week, several of the most thought-provoking moments of the proceedings came when Kearns-Sayre syndrome patient Sharon Reeder spoke from the patient’s perspective.

Diagnosed 14 years ago, Reeder had more than one emperor’s-new-clothes-type observation about oocyte modification for preventing mitochondrial disease in future generations.

For one thing, such prevention can only work for mothers who have been diagnosed. It took 16 years for Reeder to be diagnosed after her first symptoms appeared, and her diagnosis has evolved over the years. Given how differently mitochondrial disease presents, finding those who would benefit from oocyte modification is no trivial thing.

Even assuming that patients could be identified – which may indeed become easier as sequencing becomes more routine – the next question is whether what’s best for them is really to enable them to have children who share their nuclear DNA.

Risky pregnancies for women who won’t benefit

Oocyte modification does not cure anyone of anything. The children who will purportedly one day be in better health because of it only exist because of the technique in the first place, and their mothers will still have mitochondrial disease.

Because mitochondria are the energy producers of cells, the extra energy demands of pregnancy can make pregnancy extremely difficult and medically risky for women with mitochondrial disease, even for those who have had mild symptoms before pregnancy.

Then, whether the pregnancy has been difficult or easy, the women will have to face the demands of caring for a newborn. And the way the clinical trials were currently being envisioned, they would probably be taking care of that newborn in addition to an older disabled child.

I am not arguing that the science, or such pregnancies, should not proceed because of those risks to the mother. That is for the patients to say ‑ overall, permitting women to make decisions about their fertility is far better than the alternative.

But those arguing that this is nothing more than a way of expanding choice have to permit discussion – and might do well to ask themselves – about whether in the big picture, using germline engineering to encourage what can be dangerous pregnancies in chronically ill people is really the best way for options to be expanded for women with mitochondrial disease, their potential children, and society as a whole. Choices are not made in a vacuum. And not every choice is an equally good one.

At the advisory committee meeting, Reeder ‑ who has a son – took care to note that she sees the benefits of expanding the options, and understands how heartbreaking reproductive issues can be.

But she also said at one point that while listening to the meeting proceed, she had been thinking, “wouldn’t it be great if all this research was about therapies to help those of us whose lives are severely affected by mitochondrial disease?”

]]>http://www.bioworld.com/perspectives/2014/03/04/human-germline-engineering-moms-picture/feed/0Grappling with the Ethicshttp://www.bioworld.com/perspectives/2012/09/05/grappling-with-the-ethics/
http://www.bioworld.com/perspectives/2012/09/05/grappling-with-the-ethics/#commentsWed, 05 Sep 2012 13:45:51 +0000Mari Serebrovhttp://www.bioworld.com/perspectives/?p=1116With science boldly taking us where we’ve never gone before, we’re exploring new worlds and stretching the boundaries of our universe. While these are exciting times for the adventurer in us, they can be discomfiting for our inner ethicist. From...

]]>With science boldly taking us where we’ve never gone before, we’re exploring new worlds and stretching the boundaries of our universe. While these are exciting times for the adventurer in us, they can be discomfiting for our inner ethicist.

From cloning to stem cell research to genetic testing to patent eligibility to drug pricing to compassionate use to quality-of-life issues, we face a growing number of decisions fraught with moral and ethical questions that cannot be easily answered in a lab or by a textbook. What once were merely philosophical debates about the future promise of science have become gut-wrenching decisions focused on the here-and-now realities of what science is capable of today.

Dealing with these realities is tough enough on a personal level. It becomes infinitely more difficult to answer such questions on a state or national level, knowing that the answers could impact millions of lives. The late Fay Boozman, then head of the Arkansas Department of Health, clued me in on that struggle.

A soft-spoken, compassionate doctor, Fay lived his life to help others. The last time I saw him, Fay was agonizing over health policy decisions he had to make. He confided that because of the advances in science and technology, there were situations in which he didn’t even know how to apply the moral test that had guided his life.

I sensed that same soul searching among a few judges in two recent court decisions involving health care.

One of the cases, a vaccine suit, involved a request for an en banc rehearing in the U.S. Court of Appeals for the Federal Circuit. The denial of the en banc essentially upheld the court’s decision to deny two families compensation under the Vaccine Act when their infants developed Dravet’s syndrome after receiving a second diphtheria-tetanus-acellular pertussis vaccination.

The government conceded that the vaccine triggered the seizures that marked the onset of the disorder, which ordinarily would have led to compensation. But in these cases, the government denied causality because a genetic test, post-vaccination, showed the two girls had a DNA mutation in the SCN1A gene that could have eventually produced the disorder anyway.

In the lone dissent to the Federal Circuit’s decision to deny the rehearing, Judge Pauline Newman said, “These cases raise an important new principle, one that is fundamental to the Vaccine Act, and that could not have arisen but for recent advances in genetic science.”

The Vaccine Act was designed to help the small percentage of children who were injured by vaccines, Newman said. In the past, no one understood why these children were harmed. While genetic testing is now explaining the why, it should not circumvent the need to compensate the families of the children endangered by a vaccination, the judge argued.

(The genetic advances beg a few questions. Now that we know some of the why, should all children undergo genetic testing before they’re vaccinated? If so, are we, as a society, willing to cover that extra cost? If not, are we willing to continue compensating families whose children were perhaps needlessly harmed by a vaccination?)

The other case, Sherley v. Sebelius, involved federal funding of embryonic stem cell research. Although Judge Janice Rogers Brown concurred with the U.S. Court of Appeals for the District of Columbia Circuit decision to uphold the funding, she acknowledged serious concerns that “should trouble the heart.”

Noting that Congress has grappled with the ethical challenges rising from advances in biotechnology, Brown said, “Disagreement is inevitable when what lies at the core of the dispute is a profound question about the boundaries of science – one that is irreducibly controversial because the slippery slope is precipitous in both directions.”

Quoting James Thompson, the researcher credited with being the first to successfully derive human embryonic stem cells, Brown said, “‘If human embryonic stem cell research does not make you at least a bit uncomfortable, you have not thought about it enough.’”

I’m glad these judges wrestled with their decisions. Dealing with such issues should never be easy. And I’m glad they shared their struggle. Perhaps they will inspire other judges and policymakers to engage in some soul searching instead of minimalizing these debates by reducing them to academic or legal exercises.